Tbwa Chiat/Day Inc
Director, Ethics & Compliance Business Partner
Tbwa Chiat/Day Inc, Trenton, New Jersey, United States,
Director, Ethics & Compliance Business Partner
Somerset, New Jersey, United States Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a
Director, Ethics & Compliance Business Partner
as part of the
Compliance
team based in
Somerset, NJ . Role Overview This role is responsible for overseeing the engagement of external stakeholders, providing subject matter expertise and leading the development of both global and regional policies, training, and communications as needed, reviewing various materials, tactics, and engagement requests for compliance, and providing consultation to business partners across medical, clinical, and commercial functions. The position reports directly to the Global Head of Compliance and works closely with other senior leaders to align compliance strategies. Key Responsibilities Collaborating with the Global Operations Senior Director and other compliance leaders to ensure cohesive and integrated efforts Advising internal stakeholders on compliance risks associated with external engagements Overseeing the processes and systems associated with engagement of HCPs / HCOs (FMV, Contracting, etc.) Guiding the development and oversight of compliance frameworks for interactions with key external stakeholders Providing compliance consultation to business partners across medical, clinical, and commercial functions Overseeing product material reviews to ensure compliance with corporate standards Contributing to the development of compliance policies Conducting live training sessions to educate business partners Requirements
Solid experience in a global biotech company with a proven track record of managing projects requiring significant stakeholder involvement Bachelor's degree in a related field (compliance) Knowledge of OIG seven elements Experience working with Commercial and Medical Affairs Knowledge of adboards, speaker programs, FMV Significant experience working as a compliance advisor, business partner or consultant Strong understanding of compliance processes and activities common to the biotech/pharmaceutical industry Strong understanding of healthcare compliance and enforcement environment Familiarity with False Claims Act, Anti-kickback Statute, anti-bribery considerations, and CDE rules and regulations Ability to develop strong trusting and productive relationships within and across business areas to seek alignment on objectives and achieve results Ability to work independently and prioritize in a rapid growth environment, with a sense of urgency Excellent written and oral communication skills High level of integrity with good ethical core values Excellent time management and organizational skills with strong attention to detail, organizational, analytical, and people skills
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Somerset, New Jersey, United States Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a
Director, Ethics & Compliance Business Partner
as part of the
Compliance
team based in
Somerset, NJ . Role Overview This role is responsible for overseeing the engagement of external stakeholders, providing subject matter expertise and leading the development of both global and regional policies, training, and communications as needed, reviewing various materials, tactics, and engagement requests for compliance, and providing consultation to business partners across medical, clinical, and commercial functions. The position reports directly to the Global Head of Compliance and works closely with other senior leaders to align compliance strategies. Key Responsibilities Collaborating with the Global Operations Senior Director and other compliance leaders to ensure cohesive and integrated efforts Advising internal stakeholders on compliance risks associated with external engagements Overseeing the processes and systems associated with engagement of HCPs / HCOs (FMV, Contracting, etc.) Guiding the development and oversight of compliance frameworks for interactions with key external stakeholders Providing compliance consultation to business partners across medical, clinical, and commercial functions Overseeing product material reviews to ensure compliance with corporate standards Contributing to the development of compliance policies Conducting live training sessions to educate business partners Requirements
Solid experience in a global biotech company with a proven track record of managing projects requiring significant stakeholder involvement Bachelor's degree in a related field (compliance) Knowledge of OIG seven elements Experience working with Commercial and Medical Affairs Knowledge of adboards, speaker programs, FMV Significant experience working as a compliance advisor, business partner or consultant Strong understanding of compliance processes and activities common to the biotech/pharmaceutical industry Strong understanding of healthcare compliance and enforcement environment Familiarity with False Claims Act, Anti-kickback Statute, anti-bribery considerations, and CDE rules and regulations Ability to develop strong trusting and productive relationships within and across business areas to seek alignment on objectives and achieve results Ability to work independently and prioritize in a rapid growth environment, with a sense of urgency Excellent written and oral communication skills High level of integrity with good ethical core values Excellent time management and organizational skills with strong attention to detail, organizational, analytical, and people skills
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